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About Friends

Friends of Cancer Research drives collaboration among partners from every healthcare sector to power advances in science, policy, and regulation that speed life-saving treatments to patients.

THE POWER OF COLLABORATION

During the past 20-plus years, Friends of Cancer Research (Friends) has been instrumental in the creation and implementation of policies ensuring patients receive the best treatments in the fastest and safest way possible. We’ve been successful due to our ability to convene the right people at the right time and put forth revolutionary, yet realistic ideas. We are energized now more than ever to continue this critical work with our trusted partners, creating innovative solutions to overcome barriers standing in the way of conquering cancer. Below are highlights of our collaborations and active initiatives within our four main areas of focus.

DRUG DEVELOPMENT

BREAKTHROUGH THERAPY: AN APPROVAL PATHWAY THAT REWARDS INNOVATION

When new drugs aimed to treat serious and life-threatening conditions show unprecedented effect in early clinical testing, patients shouldn’t have to wait to receive treatment. To address this complex problem, Friends worked with partners in advocacy, regulation, drug development, and bipartisan Congressional champions to take the Breakthrough Therapy Designation from an innovative concept, to scientific whitepaper, to federal law in just 13 months. This resulted in the passage of an expedited FDA development program that ensures patient access to revolutionary drugs as quickly and effectively as possible.

The concept was initiated at our Annual Meeting, with an expert working group which proposed strategies to expedite FDA approval of exceptional drugs intended to treat a serious or life-threatening disease and preliminary clinical evidence suggests it provides a substantial improvement over existing therapies, without sacrificing safety and efficacy standards

The program has seen upwards of 700 requests, with more than 250 designations and more than 100 approvals.

Tumor mutational burden (TMB) measures the quantity of mutations found in a tumor. This type of biomarker is currently under study to evaluate whether it may help predict the likelihood a patient with cancer will benefit from immuno-oncology (IO) therapies. Currently, there is a significant lack of standardization for TMB calculation and reporting.

To achieve consistency and accurate reporting across tests, Friends is engaging stakeholders across all health sectors to review the current methods of TMB calculation and reporting. Friends is proposing analytical and clinical validation studies to support a standardized method of TMB measurement, which will help improve patient care through consistent TMB reporting in a clinical setting despite differences in the testing panel used. Ultimately, Friends is helping to ensure consistent identification of patients who are likely to respond to IO therapies.

Eligibility criteria are necessary in clinical trials to define the patient population, isolate the potential effect of an investigational drug, and ensure that the trial is conducted safely. However, excessive or overly rigid eligibility criteria may impair the rate of trial accrual, restrict patient access to investigational drugs, and limit the ability to generalize the results to the broader population of patients. In 2016, the American Society of Clinical Oncology (ASCO) and Friends began a joint project to develop and advance specific strategies to change the exclusionary nature of eligibility criteria.

On October 2, 2017, an ASCO-Friends joint research statement and four supporting manuscripts on the topic were published in the Journal of Clinical Oncology.

On August 9, 2018, ASCO and Friends submitted jointly to the Food and Drug Administration (FDA) recommended language for five guidance documents on ways to broaden eligibility criteria for cancer clinical trials. FDA plans to review the ASCO-Friends recommended language as the agency finalizes draft guidance documents to release for public comment.

THE FUTURE OF TREATING CANCER: IMMUNOTHERAPIES

Friends is working to further the field of immuno-oncology through the development of a Policy Advisory Group consisting of a small, but representative group of scientific, clinical, patient, policy and industry thought leaders. These thought leaders will shape a multi-stakeholder process to pave the way for this exciting new science. In April of 2016, Friends became a launch partner of The Parker Institute for Immunotherapy, with Friends Chair, Ellen Sigal, serving on the institute’s advisory committee.

21ST CENTURY POLICIES: SCIENCE & INNOVATION FOR THE 21ST CENTURY

Friends was a primary driver of one of the most significant health-related legislative actions of Congress, the 21st Century Cures Act. The Act passed the House on November 30, 2016 by a vote of 392-26 and the Senate by a vote of 94-5, shortly before President Obama signed it into law on December 13, 2016.

Friends developed key sections of the bill that represent substantive changes that will improve outcomes for patients, and we continue to work with Congress, the FDA, and other regulators as they implement the legislation and help bring scientific advances through an improved and streamlined regulatory process.

POLICY RESEARCH & ANALYSIS

SAFEGUARDING THE PUBLIC HEALTH: ENHANCING INFORMATION ABOUT PRESCRIPTION DRUGS

Patients, caregivers, and their physicians and nurses need high quality sources of information about the prescription drugs they use. While many sources of information exist, none can deliver as strong assurances of reliability and scientific accuracy as FDA-approved product labels. Friends data shows that most cancer drug labels are currently out of date.

Following a congressional briefing, the release of a study on outdated labeling, and a panel at the Friends Annual Meeting, Friends is developing a set of proposals to ensure that important information is added to labels where it is currently absent. Friends proposed ways for FDA to play a more active role in facilitating timely inclusion of new information on labels, particularly for generic drugs and older, off-patent products.

Friends is actively pursuing a bipartisan piece of legislation.

DIAGNOSTIC DEVELOPMENT

CREATING A BLUEPRINT: DRUG/DIAGNOSTIC CO-DEVELOPMENT

While cutting-edge drugs have access to special FDA pathways and approval mechanisms, the addition of companion diagnostics that enable their use can complicate the regulatory process. Through our annual “Blueprint” forum, with our partners at Alexandria Real Estate Equities, Inc., we develop innovative solutions and approaches to address the challenges of drug/diagnostic co-development. Major outcomes of this forum include:

Ways to overcome the challenges associated with biomarker development;

Optimal development of diagnostics with breakthrough therapies;

A regulatory framework for next-generation sequencing as a companion diagnostic; and

A standardized approach to increasing utilization and sharing of large-scale genetic databases.

EDUCATION & ADVOCACY

PROGRESSFORPATIENTS.ORG: ADVOCACY ALLIANCE & EDUCATION

Advocacy Education: Patient advocates devote their time, energy, and resources to help patients, and to make the greatest impact they need the knowledge and understanding of the laws and regulations affecting the process of new treatments for patients and the institutions that are involved in that process. That is why Friends developed our Advocacy Education program. Through this training program, advocates will acquire the necessary tools to effectively communicate with drug researchers, developers, and regulators enabling them to make the connections necessary to engage with all sectors who need to be better guided by patient input.

Advocacy Alliance:Friends’ Advocacy Alliance serves as a portal to stay informed on the most pressing policy issues, current proposals, and national priorities in regulatory science. The Alliance provides resources and a platform for organizations to join Friends as we engage Congress and federal health agencies on the latest issues.